Land: Nya Zeeland
Språk: engelska
Källa: Medsafe (Medicines Safety Authority)
Octocog alfa 500 [iU]
Bayer New Zealand Limited
Octocog alfa 500 IU
500 IU
Injection with diluent
Active: Octocog alfa 500 [iU] Excipient: Calcium chloride dihydrate Glycine Histidine Polysorbate 80 Sodium chloride Sucrose Water for injection Water for injection
Combination pack, vial + diluent syringe, 500 IU
General sale
General sale
Bayer Healthcare LLC
KOGENATE FS is indicated in congenital Factor VIII deficiency (haemophilia A) for the treatment and prophylaxis of bleeding in untreated and previously treated patients without inhibitors.
Package - Contents - Shelf Life: Combination pack, vial + diluent syringe - 500 IU - 30 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze). Single excursion of up to 6 months at or below 30°C. 3 hours reconstituted stored at or below 25°C - Syringe, glass, prefilled; diluent WFI - 2.5 mL - 48 months from date of manufacture stored at or below 25°C. (30°C if from Bayer) - Vial, glass, prefilled; diluent WFI - 2.5 mL - 48 months from date of manufacture stored at or below 25°C - Vial, glass, powder for injection: options on overseal - Aluminium, BIO-SET & MEDI-MOP - 500 IU - 30 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light. Single excursion of up to 6 months at or below 30°C.
1998-08-18
KOGENATE ® FS with vial adapter CMI Page 1 of 6 KOGENATE ® FS (with vial adapter) octocog alfa (bhk) (recombinant Factor VIII) CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about KOGENATE FS. This leaflet does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking KOGENATE FS against the benefits they expect it will have for you. KOGENATE FS should only be used under medical supervision. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT KOGENATE FS IS USED FOR KOGENATE FS will both help to prevent and treat bleeding, occurring either spontaneously or due to injury, and bleeding during emergency and surgical procedures, by temporarily providing additional Factor VIII. BEFORE YOU USE KOGENATE FS _ _ _WHEN YOU MUST NOT USE IT _ Do not use KOGENATE FS if you have an allergy to: • any medicine containing octocog alfa (bhk) (recombinant Factor VIII) • any of the ingredients listed at the end of this leaflet Some of the symptoms of an allergic reaction may include: • shortness of breath • wheezing or difficulty breathing • swelling of the face, lips, tongue or other parts of the body • rash, itching or hives on the skin As KOGENATE FS contains trace amounts of mouse and hamster proteins, a possibility exists that patients treated with this product may develop hypersensitivity to these non- human proteins. If you experience any of these symptoms, you should stop the injection at once and seek medical attention immediately. DO NOT USE KOGENATE FS AFTER THE EXPIRY DATE (EXP) PRINTED ON THE PACK. The expiry date is printed on the carton and vial after “EXP” (e.g. 3 NOV 18 refers to 3 November 2018). If it has expired return it to your pharmacist for disposal. DO NOT USE THIS MEDICINE IF THE PACKAGING IS TORN OR Läs hela dokumentet
1902 KOGENATE Page 1 of 13 NEW ZEALAND DATA SHEET 1 PRODUCT NAME KOGENATE® FS (with vial adapter) octocog alfa (bhk) 250 IU Injection with diluent KOGENATE® FS (with vial adapter) octocog alfa (bhk) 500 IU Injection with diluent KOGENATE® FS (with vial adapter) octocog alfa (bhk) 1000 IU Injection with diluent KOGENATE® FS (with vial adapter) octocog alfa (bhk) 2000 IU Injection with diluent KOGENATE® FS (with vial adapter) octocog alfa (bhk) 3000 IU Injection with diluent 2 QUALITATIVE AND QUANTITATIVE COMPOSITION KOGENATE FS is available in the following dose strengths: TABLE 1. AVAILABLE DOSE STRENGTHS AND APPROXIMATE CONCENTRATION OF RECONSTITUTED KOGENATE FS KOGENATE FS dose strengths Concentration of reconstituted KOGENATE FS 250 IU ~ 100 IU/mL 500 IU ~ 200 IU/mL 1000 IU ~ 400 IU/mL 2000 IU ~ 400 IU/mL 3000 IU ~ 600 IU/mL Each vial of KOGENATE FS contains the labelled amount of octocog alfa (bhk) [Factor VIII] in International Units (IU). One IU, as defined by the World Health Organisation standard for blood coagulation Factor VIII, human, is approximately equal to the level of Factor VIII activity found in 1.0 mL of fresh pooled human plasma. One single-use vial with lyophilisate for injection or infusion contains: Active ingredient: octocog alfa (bhk) (nominal dose of 250, 500, 1000, 2000, or 3000 IU). Excipients: 250, 500, 1000 IU: One vial with lyophilised powder contains 58 mg glycine, 4.4 mg sodium chloride, 0.7 mg calcium chloride, 8 mg histidine, 200 µg polysorbate 80 and 28 mg sucrose. 2000, 3000 IU: One vial with lyophilised powder contains 110 mg glycine, 8.6 mg sodium chloride, 1.3 mg calcium chloride, 15.2 mg histidine, 400 µg polysorbate 80 and 52 mg sucrose. For the full list of Excipients, see section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Injection with diluent 4 CLINICAL PARTICULARS 4.1 Therapeutic indications KOGENATE FS is indicated in congenital Factor VIII deficiency (haemophilia A) for the treatment and prophylaxis of bleeding in untreated and previously treated patients Läs hela dokumentet